Basel, 17 September 2009 Study shows MabThera maintenance treatment delays disease progression in patients with incurable lymphoma Results show patients treated with MabThera as initial and follow-on therapy stay in remission for longer.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today results from the international phase III study PRIMA1, which show that MabThera (rituximab) maintenance therapy can significantly increase the time until the disease progresses in newly-treated patients with advanced follicular lymphoma, a common and slow-developing but incurable form of lymphoma.
Results from PRIMA show that previously untreated patients receiving MabThera and standard chemotherapy induction treatment followed by MabThera alone (known as maintenance therapy) were able to live without their disease progressing for longer than those receiving MabThera and standard chemotherapy induction with no follow-on treatment.
“The positive findings of the PRIMA study will help ease the suffering of people living with follicular lymphoma,” said Prof. Gilles Salles, Centre Hospitalier Lyon Sud, France and principal investigator for the PRIMA trial. “While advances in treating follicular lymphoma mean it is now considered a chronic illness rather than a terminal one, we continue to seek ways of prolonging the time that patients are in remission so they are free of the effects of their disease. This trial shows for the first time that MabThera maintenance therapy given immediately after induction with a MabThera- associated chemotherapy regimen is a successful treatment strategy for patients with previously untreated follicular lymphoma.”
Follicular lymphoma is a common type of non-Hodgkin’s lymphoma (NHL), accounting for about one in four of all cases. It can occur at any time during adulthood, though people are typically diagnosed during their sixties, and affects as many men as it does women. It is a low-grade lymphoma, which means that it usually develops slowly.2
Data from the trial will be submitted for presentation at an upcoming international medical meeting and will be filed with EU and US health authorities to extend the current label for MabThera. In the EU, MabThera is currently indicated as a maintenance therapy for patients with relapsed or refractory follicular lymphoma who have responded to induction chemotherapy with or without MabThera. In the US, Rituxan is approved for patients with non-progressing, first-line, follicular CD20-positive non Hodgkins lymphoma after first-line CVP (cyclophosphamide, vincristine, prednisone) therapy.
About PRIMA
The PRIMA study is a randomized international phase III study, sponsored by the Groupe d’Etudes de Lymphomes de L’Adulte (GELA) in France and conducted in collaboration with Roche. It included 1217 patients with previously untreated advanced follicular lymphoma and was conducted at 222 study sites across 25 countries. The study was designed to evaluate the efficacy and safety of two-year MabThera maintenance therapy in responders to induction therapy with MabThera plus chemotherapy. The primary endpoint of the study was to show an increase in terms of median progression free survival.
About MabThera
MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then recruits the body’s natural defences to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.
In oncology, MabThera is indicated in the EU:
. For the treatment of patients with previously untreated or relapsed/refractory chronic lymphocytic leukaemia (CLL) in combination with chemotherapy
. For the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy
. As maintenance therapy for patients with relapsed/refractory follicular lymphoma responding to induction therapy with chemotherapy with or without MabThera
. For the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy
. As monotherapy for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy
In addition, in rheumatology MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
MabThera is known as Rituxan in the United States, Japan and Canada. Over 1.9 million patient exposures with MabThera have been recorded worldwide since its launch.
Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims to provide medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
